Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients

Ketamine

Brief Summary

The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.

Intervention / Treatment

  • Ketamine full dose (DRUG)
    This group will receive induction of anesthesia using Ketamine 1 mg/Kg.
  • Midazolam (DRUG)
    This group will receive midazolam 0.05 mg/Kg
  • Normal saline (DRUG)
    This group will receive normal saline 10 mL
  • Ketamine half dose (DRUG)
    This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.
  • Lidocaine (DRUG)
    This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.

Condition or Disease

  • Septic Shock

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 43 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Feb 20, 2019 ACTUAL
    Primary Completion: Sep 20, 2019 ACTUAL
    Completion Date: Sep 20, 2019 ACTUAL
    Study First Posted: Feb 19, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 23, 2019

    Sponsors / Collaborators

    Lead Sponsor: Cairo University
    Responsible Party: N/A

    Location

    Cairo, Egypt

    Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.

    Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.

    Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.

    Participant Groups

    • This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.

    • This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Adult patients aged above 18 years
    * With septic shock
    * Scheduled for general anesthesia

    Exclusion Criteria:

    * Patients under 18 years
    * Burn patients

    Primary Outcomes

    • Mean arterial blood pressure measured in mmHg

    Secondary Outcomes

    • Number of heart beats per minute

    • The number of patients who suffer from decreased mean arterial pressure by 10% from the baseline reading during the first 5 minutes after induction of anesthesia

    • Volume of blood pumped by the heart in one minute measured in liters per minute

    • The total dose of norepinephrine measured in micrograms

    • Systolic arterial blood pressure measured in mmHg

    More Details

    NCT Number: NCT03844984
    Other IDs: N128-2018
    Study URL: https://clinicaltrials.gov/study/NCT03844984
    Last updated: Sep 29, 2023